Intacts

Intacs is the brand name for a medical device that is used in the treatment of the eye disorder known as keratoconus. Intacs is the trademark name for micro-thin prescription inserts which were previously used as a form of refractive surgery in the treatment of low levels of myopia or nearsightedness, but has recently received FDA approval for keratoconus.

FDA Approval

Intacs were approved under a Humanitarian Device Exemption (HDE) by the FDA in July 2004, allowing Intacs to be used for treating keratoconus. As part of the HDE approval, Addition Technology, the manufacturer of Intacs, has implemented an extensive training program in which each surgeon will be required to participate.

What Is Keratoconus?

Keratoconus is a condition in which the cornea (the clear, central part of the front surface of the eye) bulges outward like a cone. Normally, the cornea has a dome shape, like a ball. Sometimes, however, the structure of the cornea is just not strong enough to hold this round shape. Keratoconus can cause progressive deterioration of vision. Initially, keratoconus is treated with glasses, but often, contact lenses, first soft, then gas permeable, are necessary to allow the eye to see adequately. In approximately 10% to 15% of cases, however, medical management is insufficient, and surgery is necessary to improve vision.

How Are Intacs Used?

Intacs are clear plastic arcs that are designed to be inserted into the substance of the cornea in people who have keratoconus and who can no longer see properly with glasses or contact lenses. Intacs were approved by the FDA for treatment as an alternative to corneal transplant, which is a standard treatment for keratoconus.

When they are inserted into the eye, Intacs reshape the cornea by flattening it closer to its original dome shape. Although the procedure usually improves uncorrected vision, the patient will often still need glasses or contact lenses after the Intacs are inserted. After the cornea has been reshaped, patients who were once unable to tolerate contact lenses may be able to return to contact lens wear and see even better than they did with the lenses prior to surgery. Some patients may even be able to see well enough to go back to simply wearing glasses.

How Is the Intacs Procedure Performed?

The procedure to insert Intacs is usually done in an outpatient surgery center. This is what happens:

The doctor numbs the patient’s eye with a topical anesthetic.

To keep the eye open, the doctor places a speculum in the eye. This also keeps the patient from blinking and possibly interfering with the procedure.

The doctor makes a small incision in the cornea and places a centering guide on the eye to keep it steady. This also helps the doctor make sure that the Intacs will be placed properly.

After separating the layers of the cornea, the doctor inserts the Intacs and then closes the incision with one suture.

The procedure takes less than 30 minutes to perform. Follow-up includes regular visits to the eye doctor to make sure the eye is healing properly and to determine if vision has improved.

What Are the Potential Risks of the Intacs Procedure?

Possible adverse events that may occur after an Intacs procedure include the following:

Eye infection

Problems with night vision

Seeing “halos” or glare around lights

Blurry or fluctuating vision

Who Should Not Have an Intacs Procedure?

Those who should not undergo an Intacs procedure include:

People who are under 21 years old

Pregnant women

People who can still see well with contact lenses

People whose central corneas are not clear

People who have other eye health problems that may cause future problems